ClearStrand-ASD for your patients when autism is a concern
Health Care Provider Overview
What is ClearStrand-ASD?
ClearStrand-ASD is a new biochemical test that detects a biomarker associated with autism using a single strand of hair. It is intended to aid HCPs in ruling out autism in patients aged 1 month up to 36 months when autism is a concern. Rx only. 1 2
ClearStrand-ASD is currently only available through ClearStrandASD.com and is not covered by insurance.
If you think ClearStrand-ASD is right for your patient, refer their caregiver to clearstrandasd.com to learn more and request the test through independent telehealth providers on the LinusBio patient portal.
ClearStrand-ASD for your patientsScience and Clinical Evidence
ClearStrand-ASD is a biochemical test that bridges genomics and the environment.
It maps the dynamic patterns of an individual’s unique biological response to environmental exposures over time at a molecular level.3
Hundreds of time points along a strand of hair are analyzed, and thousands of data features are generated with proprietary robotics and lasers, revealing patterns underlying an individual’s metabolism of essential and nonessential elements.3
Then, machine learning-based AI identifies whether a patient has the molecular signature - a biomarker - associated with autism spectrum disorder.3
ClearStrand-ASD is for children aged 1 month up to 36 months when autism is a concern
ClearStrand-ASD is now available in 45 states for $749 $499
Clearstrand-ASD is available for patients in all states except for those in HI, MD, NY, PA, RI, and DC.
The price includes the ordering of ClearStrand-ASD through a telehealth provider, kit shipment, testing of the sample at our CLIA-certified lab, and a post-test virtual visit to review the results.
The introductory offer of $499 is valid until 6/30/25.
To be notified when it is available in your state, fill out our contact form.
Results may support early clinical decisions about the child’s care, even before signs of autism appear. 3
Interpreting the results
ClearStrand-ASD provides an objective result of negative or non-negative
ClearStrand-ASD is not a standalone diagnostic test; HCP should determine if a child should receive a diagnostic evaluation after reviewing the test result.
ClearStrand-ASD: Autism risk assessment with high negative predictive value
Test performance is based on the intended use in children with an elevated likelihood of autism, such that prevalence of the condition in this population is 14%. 2 The overall prevalence in the US is 2.8%. 14
ClearStrand-ASD has a negative predictive value (NPV) of 92.5% in a population of children aged 1 month up to 36 months where autism is a concern. 2
From the comfort of your patient's home
Starting with just a strand of hair
If you think ClearStrand-ASD is right for your patient, refer their caregiver to this site where they can learn more and request the test through a telehealth provider on the LinusBio patient portal. The process is simple for the caregiver.
After testing is complete, you may request a copy of the results from your patient's caregiver.
Caregiver requests the test
An independent telehealth provider will assess if the child qualifies for ClearStrand-ASD, the caregiver will provide payment information, and then the telehealth provider will place the order.
Caregiver provides child's hair sample
The caregiver will collect a hair sample and return it to LinusBio's laboratory in the postage-paid collection box. The result will be ready within 15 business days after the sample is received at the lab.
Caregiver reviews results with the ordering telehealth provider
The telehealth provider who ordered the test for the child will review the results with the caregiver and discuss their recommendations for next steps.
FAQs for HCPs
ClearStrand-ASD demonstrated a:
- negative predictive value (NPV) of 92.5%
- positive predictive value (PPV) of 17.4%
- sensitivity of 81.4%
- specificity of 37.2% 2
The test performance was validated in a study including patients with an elevated likelihood of autism. Each test result was compared to a reference diagnosis made by a specialist clinician based on DSM-5 criteria. 2
NPV and PPV are reported based on a 14% prevalence, which reflects the test’s intended use population of children aged 1 month up to 36 months where autism is a concern. The prevalence of autism in the general population is 2.8%. 14 Prevalence is the number of people in a particular population that have a condition, relative to all the people in that population. Prevalence is typically shown as a percentage (such as 2.8%) or a proportion (such as 1 in 36).15
Since the purpose of ClearStrand-ASD is to aid health care providers in ruling out autism, a key performance characteristic is NPV. NPV shows the probability that an individual with a negative result does not have the condition.16
ClearStrand-ASD has an NPV of 92.5% (95% Wilson Confidence Intervals 83.7%, 96.7%). 2 When the biomarker is not detected, the test result is negative, and there is a 92.5% probability that the child will not receive a diagnosis of autism if they are evaluated by a specialist.
ClearStrand- ASD is not intended for the purpose of identifying autism. When the biomarker is detected, the test result is non-negative, and there is a 17.4% probability that the child will receive a diagnosis of autism if they are evaluated by a specialist. A health care provider could decide that the child should receive an autism evaluation based on a non-negative result because the probability that the child may receive an autism diagnosis is higher than in the general population.
ClearStrand-ASD has a sensitivity of 81.4% and a specificity of 37.2%.2 Sensitivity is the measure of the ability of a test to correctly detect a condition when it is present. More precisely, sensitivity is the probability the test result is non-negative when autism is present. Specificity is a measure of the ability of a test to correctly exclude a condition when it is absent. More precisely, specificity is the probability the test result is negative when autism is absent.17
No, the biomarker reflects the dynamics of elemental metabolism, not concentrations of metals in hair. 5
Support your patients in getting the advantage of objective insights
Recommend ClearStrand-ASD for your patients when autism is a concern.
Important information
ClearStrand-ASD is a biochemical test intended to help health care providers rule out autism spectrum disorder (ASD) when it is a concern in children aged 1 month up to 36 months of age. It detects a biomarker associated with autism using a strand of hair. ClearStrand-ASD must be ordered by a licensed health care provider. Rx only. ClearStrand-ASD results can be negative or non-negative.
A child with a negative result is unlikely to be on the autism spectrum. A child with a non-negative result may need further autism diagnostic evaluation. ClearStrand-ASD is not a standalone diagnostic test. Health care providers should consider the test result in the context of other factors relevant to their clinical decision making. ClearStrand-ASD analyzes a strand of hair to map the dynamic patterns of an individual's unique biological response to environmental exposures over time at a molecular level and uses an algorithm to assess the likelihood of autism from the patterns. It is not a genetic test.
The test is performed by the LinusBio CLIA-certified laboratory (CLIA #31d2307499) and has not been cleared or approved by the US Food and Drug Administration (FDA).